Arm 2 will get FMT (Fecal Microbial Transplant) with Healthy Donor Stool and high dose 5-ASA (Pentasa). The FMT is done through colonoscopy.

fecal microbial transplant
FMT

Fecal Transplant via Colonoscopy.

Primary Outcomes

Measure

The primary endpoint is disease remission based on PUCAI scores (<10).

time frame:
12 Months

Secondary Outcomes

Measure

Secondary endpoints will include change in mucosal inflammation reflected on laboratory studies.

time frame:
12 Months

Eligibility Criteria

Male or female participants from 7 years up to 21 years old.

Inclusion Criteria
1. Age: 7-21 who have been diagnosed with ulcerative colitis
2. Mild to moderate disease based on PUCAI with a score of 10-64
3. Need for colonoscopy
Exclusion Criteria
1. Children who are known to be resistant to steroid therapy, immunomodulators and
biologics, or on a steroid dose greater than 0.5 mg/kg/day (maximum 20 mg)
2. Children with recent dose change of biologics (within 4 weeks), 5-ASA, steroids or
immunomodulators (within 4 weeks)
3. Allergy to or intolerance of mesalamine or 5-ASA products
4. Any evidence of infectious colitis
5. Concurrent infections that require anti-microbial therapy (such as abdominal abscess,
pneumonia, etc…)
6. Unable to give informed consent/assent
7. Have received probiotic preparations ≤ 4 weeks prior to randomization
8. Pregnancy and breast feeding in patient subjects of childbearing potential
9. Subjects with significant renal and liver dysfunction (creatinine > 2 mg/dl and
direct bilirubin > 2 mg/dl), Subjects with congenital or acquired immunodeficiency,
or who are immunosuppressed due to conditions other than ulcerative colitis (such as
neoplastic disease or organ transplantation), have received or are receiving
chemotherapy, or have been diagnosed with HIV.

Additional Information

Official title

The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis

Principal investigator

Sonia Michail, MD

Description

The enteric microbiota is now accepted as an important etiologic factor in the pathogenesis
of human Inflammatory Bowel Disease (IBD) and immune-mediated chronic experimental
intestinal inflammation, with ample data to implicate the microbiome as a main factor in the
occurrence of IBD. This can be inferred from animals in germ-free environment which can
protect from experimental colitis. In addition, increased gut permeability due to dysbiosis,
is frequently seen in patients with IBD even in remission and, similarly, first degree
relatives of IBD. Therefore, it is not surprising that therapeutic interventions aiming at
modifying the gut microbiome would be of therapeutic benefit. Ulcerative colitis is a
condition that is characterized by chronic inflammation of the colon. It is an important
pediatric disease as 25% of all cases begin in childhood and its incidence is continuously
on the rise. It is believed to be related to a genetically and environmentally-generated
altered immune response to the enteric microbiome. Previous work in the PI's laboratory
suggests that children harbor a unique gut microbial profile, which can predict therapeutic
response. Therefore, modifying the gut microbiome may result in therapeutic benefit.
However, attempts to modify the gut microbiome were largely unsuccessful until the advent of
fecal transplant, which is a new approach in treating colitis. Fecal microbiota transplant
(FMT) has been introduced several decades ago in an attempt to restore the gut microbial
balance and it appears to be a more efficient method to effectively change and sustain the
gut microbial composition. To date there have been a number of successful reports to suggest
control of disease activity and in some cases cure of the disease. This study aims to
further determine the safety and efficacy of FMT in treating children with ulcerative
colitis

Trial information was received from ClinicalTrials.gov and was last updated in November 2016.